Warning

FigureDespite widespread adoption of independent checks for administering intravenous chemotherapy there remain very few such safeguards for oral chemotherapies, new research indicates. In the study, now online ahead of print in the Journal of Oncology Practice (doi: 10.1200/JOP.2015.005892), Canadian researchers observed and interviewed 28 staff members at cancer center clinics, one cancer center pharmacy, and four community pharmacies. A total of 57 systematic independent checks for intravenous chemotherapy were found, but only six for oral agents. When partial checks were included there were 64 checks for IV medications and 17 for orally administered drugs. Although the study focused on processes in Nova Scotia, recent investigations in the United States have similarly found major shortcomings. The research was led by Melissa C. Griffin, MHSc, a clinical engineer at the Techna Institute, HumanEra, of the Centre for Global eHealth Innovation, University Health Network in Toronto, and involved other researchers at UHN, the University of Toronto, and Dalhousie University in Nova Scotia. They wrote that to their knowledge this is the first head-to-head comparison of systematic checks and safeguards for oral versus IV chemotherapy drugs. “With oral chemotherapy, I think the clinical team has less control over the downstream steps of the process, and as such it will become increasingly important for oncologists to embrace the community pharmacist, patient, and their families as core team members,” Griffin said in an interview. No systematic independent checks by any qualified health care provider were found for planning and administration of oral agents or for ordering and dispensing them. Community pharmacists were the only qualified health care professionals involved in any systematic independent checks, unlike IV chemotherapy where oncology pharmacists play a primary role during planning, ordering, and dispensing, she said. “As part of a health care system, I think we should be taking steps to improve not only our system of independent checks, but also to consider other safeguards that could support community pharmacists, as well as patients and families as they take on the responsibility for managing oral chemotherapy medications. “Community pharmacists are ideally positioned to manage a patient's oral chemotherapy, but they must first be empowered to do so,” she noted, pointing to a recent study that found that community pharmacists often lack expertise and education related to oral chemotherapy. Even so, they were quite willing to take on a more active role in patient safety, she said. “Community pharmacists often know their patients well and have a good overall picture of a patient's medications. In Canada, however, most do not have specialized training related to oral chemotherapy, nor do they have easy access to a patient's medication record. “I think these two pieces are essential: having the knowledge and expertise, and having access to key clinical information about the patient.” A Call to Action Oral chemotherapy drugs are becoming increasingly more common, with an estimated 25 percent of the 400 new cancer drugs in development being oral medications, Griffin continued. However, oral chenotherapy drugs carry unique challenges beyond the general risks associated with chemotherapy, including access, adherence, and safe handling issues. “This is potentially hazardous to the patient because IV and oral chemotherapy formulations carry comparable toxicity risks and have the potential to cause serious harm if not managed carefully,” she said. There are some signs that the issue is being taken seriously by health officials, she noted. The American Society of Clinical Oncology and the Oncology Nursing Society have both recently updated their administration safety standards to include oral chemotherapy drugs, and the Canadian Association of Provincial Cancer Agencies has developed “Oral Cancer Drug Therapy Safe Use and Safe Handling Guidelines.” While many institutions may not initially comply with such guidelines, most institutions do find they are able to comply with professional standards and make the necessary changes, according to the authors. The National Comprehensive Cancer Network has found that for IV chemotherapy in the U.S., it is common to have three or four qualified health care professionals check every dose. But this same level of involvement is often lacking for oral drugs. One recent study found that only 8.3 percent of surveyed oncologists had orders for oral chemotherapy checked by another qualified health professional. Such inconsistencies should serve as “a call to action” in the oncological community, Griffin said. She noted that in the U.S., two studies led by Saul Weingart, MD, PhD, now Chief Medical Officer at Tufts University Medical Center, found that few of the IV safeguards in routine use have been adopted for oral chemotherapy. “I think one of the challenges is the separation between where these drugs are prescribed, where they are dispensed and where they are administered; they happen in different places, and communication, assumptions and expectations can be more challenging to pin down across the system,” Griffin said. Labels, Inserts Insufficient Asked for his perspective, Michael R. Cohen, RPh, MS, President of the Institute for Safe Medication Practices (ISMP), cited a recent case involving a 60-year-old woman with brain cancer who died when she accidentally took three cycles of oral lomustine at the same time, which had been sent by an online pharmacy. Her oncologist had recommended a single dose of lomustine 150 mg, followed by a reassessment after six weeks, and she thought the pharmacy had given her one dose. She had previously been taking oral temozolomide, which she received from the pharmacy as a single dose made up of several different strength capsules every month. The example is not unique, said Cohen, noting that since 1997, ISMP has published five similar case studies in which more than one dose of lomustine was dispensed and taken. “These cases clearly demonstrate that package inserts and warning labels are insufficient,” he said. “In fact, we called three different large chain pharmacies and asked about lomustine dispensing practices, and each of the pharmacists said they would dispense multiple doses provided a patient or insurance company could pay for the drug.” Even though the package insert for lomustine repeatedly instructs pharmacists to discuss when, and how much, patients should take, patient counseling occurs infrequently except in a few states where it is mandated, Cohen said. “If it is done, counseling directives from the manufacturer may confuse patients. For example, pharmacists are directed to teach patients to take all the lomustine capsules in the container at the same time. Also, certain drug information leaflets provided to patients when dispensing lomustine contain this statement: In order that you receive the proper dose of lomustine, there may be two or more different types of capsules in the container.” A patient who is given more than a single dose of lomustine but misunderstands the directions might read this information and take all the capsules at once: “We need warnings on the prescription container label and mandatory, clear patient education and instruction at the pharmacy counter with a checklist to follow.” Real Risks Not only does the lack of independent checks pose serious toxicity risks, but the efficacy of oral chemotherapy drugs can also be compromised, added David Frank, MD, PhD, Chair of Medical Oncology Quality Improvement at Dana-Farber Cancer Institute. He pointed to a 2010 study at Dana-Farber that highlighted the potential scope of the problem. Incident reports from 14 comprehensive cancer centers, including Dana-Farber, found 99 adverse drug events due to incorrect oral chemotherapy. Of these, 20 were serious or life-threatening, 52 were deemed significant, and 25 were minor. The most common medication errors involved a wrong dose (39%), wrong drug (14%), wrong number of days supplied (11%), and missed dose (10%). “Oral chemotherapies have quickly become standard care for more and more types of cancers, but there are wide variations in how these are prescribed and monitored,” he said. “With wholesale retail pharmacies, there is very little patient counseling or follow-up. “There are a lot of weaknesses. At Dana-Farber, this has been one of the big safety issues, and we now have pharmacists and oncology nurses who conduct follow-ups with patients at home as well as instructions in multiple languages and online instructional videos on our website.”

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